NCT02409914

Brief Summary

The purpose of this study is to investigate whether higher insulin resistance in young women with Polycystic ovary syndrome (PCOS) is associated with reduced cerebral metabolic rate of glucose (CMRglu). Brain volumes using magnetic resonance imaging (MRI) and quantitative cerebral glucose uptake using dynamic positron emission tomography (PET) were obtained.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

May 2, 2019

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2015

Enrollment Period

4.5 years

First QC Date

March 27, 2015

Results QC Date

July 27, 2017

Last Update Submit

January 29, 2019

Conditions

Keywords

Insulin ResistanceBrain metabolismPETMRI

Outcome Measures

Primary Outcomes (3)

  • Global Brain Glucose PET Uptake

    Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography.

    Single point in time (day 1)

  • Brain MR Volumes

    T1-weighted brain MR images were obtained on a 1.5 Tesla scanner. Regional volumes were determined using FreeSurfer Suite 5.0 software.

    Single point in time (day 2)

  • Insulin Resistance (HOMA2-IR)

    The homeostasis model assessment computational method was used to estimate insulin resistance (HOMA2-IR) from fasting plasma glucose and insulin. The HOMA2-IR is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (normal young adult). A higher score indicates a lower insulin sensitivity.

    Single point in time (day 1 during the FDG PET)

Study Arms (1)

POLYCYSTIC OVARY SYNDROME (PCOS)

FDG PET scan,T1-weight MRI and blood were obtained for each participant

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with PCOS (n=7) were referred by physician specialist in endocrinology between March, 2010 and September, 2013. The diagnosis of PCOS was based on clinical examination using the Rotterdam criteria.

You may qualify if:

  • Diagnosis of PCOS
  • Age ≤ 35 y
  • BMI ≤ 35

You may not qualify if:

  • Taking medications for diabetes or insulin-sensitizing drugs
  • Drug addictions
  • Psychiatric illness
  • Smoking
  • Overt evidence of heart, liver or renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Stephen Cunnane
Organization
USherbrooke

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 7, 2015

Study Start

March 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 2, 2019

Results First Posted

May 2, 2019

Record last verified: 2015-04